Published in Medical Letter on the CDC and FDA, March 28th, 2010
Pirfenidone Regulatory Path - NDA and MAA
On November 4, 2009, InterMune submitted the NDA for pirfenidone to the FDA, seeking approval to market pirfenidone to reduce decline in lung function in patients with IPF. Pirfenidone has been granted Orphan Drug and Fast Track designation by...
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